Cervical cancer cells.

The Centers for Medicare & Medicaid Services (CMS) has proposed a national coverage determination (NCD) of FDG-PET imaging for cervical cancer staging in certain cases, due to its capability to “make meaningful changes in therapeutic management and improve health outcomes.”

However, CMS proposes to cover only one FDG-PET scan for staging in beneficiaries who have biopsy proven cervical cancer when the beneficiary’s treating physician determines that the FDG-PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure;
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

Also, the agency noted that there is no credible evidence that the results of FDG-PET imaging are useful to make the initial diagnosis of cervical cancer, and therefore do not improve health outcomes, and thus are not reasonable and necessary.

In May, CMS opened the NCD on FDG-PET for a limited-scope reconsideration to consider broadening national coverage--without coverage with evidence development (CED) restrictions--for the staging of cervical cancer. At the time, the requestors said that CMS may find it appropriate to exclude coverage for cervical cancer diagnosis, "since this disorder is initially diagnosed by biopsy."

The final decision is not expected until Feb. 6, 2010.

The benefits of FDG-PET imaging in oncological treatment has long been weighed by CMS. In January 2005, FDG-PET received CMS coverage with evidence development for all FDG-PET indications for brain, cervical, ovarian, pancreatic, small-cell lung, and testicular cancers and for most other cancers, except limited cervical staging conditions. In April, FDG-PET imaging received coverage for solid tumors and myeloma for most uses related to initial management, but with coverage with evidence for most uses related to subsequent management. However, CMS issued noncoverage for uses related to initial management of prostate cancer.